Global Biopharmaceutical Excipients Market - Focused Insights 2024 - 2029

BIOPHARMACEUTICAL EXCIPIENTS MARKET INSIGHTS

The global biopharmaceutical excipients market was valued at USD 2.43 billion in 2023 and is projected to grow to USD 3.79 billion by 2029, with a CAGR of 7.67% throughout the forecast period. The primary driver of this demand for excipients in producing various biological drugs is the increasing need for biopharmaceuticals. With the rising incidence of cancer and infectious diseases, there is a substantial requirement for the development of vaccines, monoclonal antibodies, and other therapies to address these conditions. Additionally, the advancement of various therapies has created a demand for the creation of innovative and multifunctional excipients.

MARKET TRENDS & DRIVERS

Need for Innovative Excipients in Biopharmaceutical Advancements

Creating new and enhanced biopharmaceutical drugs depends on cutting-edge excipients vital for sophisticated product formulations. Unlike traditional excipients, these innovative substances have not been previously utilized in FDA-approved drug formulations and do not have established food applications. Proponents emphasize their public health advantages, including improved drug delivery and potential applications in abuse-deterrent opioid formulations. Recognition by the FDA as novel excipients would assure drug developers regarding their safety, alleviating concerns during the application evaluation process. Although many approved drug excipients are documented in the FDA's Inactive Ingredient Database (IID) and have been in use for many years, novel excipients are generally excluded from this database. These excipients may be designed for new routes of administration, increased dosages, or modifications such as particle engineering. In a crucial initiative aimed at modernizing drug formulation, the FDA has launched a program to assess the safety and feasibility of novel inactive ingredients for new drugs and biologics. This effort promotes the inclusion of innovative excipients in clinical trials, offering suppliers a quicker entry to the market and fostering new therapies.

Strategic Outsourcing in the Production of Biopharmaceutical Excipients

Pharmaceutical companies are increasingly turning to outsourcing for the production of biopharmaceutical excipients, driven by several important factors. The rapid evolution of biopharmaceutical research and development has highlighted the need for specialized excipients that improve drug efficacy, stability, and delivery. These specialized materials often require intricate and expensive manufacturing processes. By outsourcing, pharmaceutical firms can concentrate on their core functions, such as drug discovery, clinical trials, and regulatory compliance, while benefiting from the know-how of specialized manufacturers. This not only streamlines operations but also speeds up the time it takes to bring new therapies to market.

Outsourcing also offers flexibility and scalability, enabling companies to adjust their manufacturing capacity as needed and comply with ever-changing regulatory standards. This adaptability is crucial for maintaining a reliable supply chain. Moreover, outsourcing can be a more cost-effective solution, as it reduces the need for substantial capital investment in in-house manufacturing facilities and allows for better resource allocation, all while upholding high standards. The combination of a need for innovation, operational efficiency, regulatory adherence, and cost savings is propelling the trend of outsourcing in this sector.

GLOBAL BIOPHARMACEUTICAL EXCIPIENTS MARKET SEGMENTATION INSIGHTS

• Insight By Excipient: The bulking agents segment holds the largest global biopharmaceutical excipients market share. Their dominance is due to their vital role in the development of advanced formulations, which enhances the overall growth of the biopharmaceutical sector. Bulking agents are essential as they provide a matrix that supports active pharmaceutical ingredients, particularly when the drug is present in minute quantities. This category encompasses various compounds such as sugars, polyols, amino acids, polymers, and proteins. Common bulking agents widely used in biopharmaceuticals include lactose, sucrose, mannitol, trehalose, dextran, and glycine. These compounds significantly contribute to improving the stability and efficacy of pharmaceutical products, especially those administered in aqueous solutions.
• Insight By Biologics: The biopharmaceutical excipients market segmented by biologics includes monoclonal antibodies, vaccines, and a diverse "others" category. The "others" segment is witnessing significant growth and holds the fastest-growing compound annual growth rate (CAGR) during the forecast period. This category encompasses cell therapies, gene therapies, growth factors, interferons, recombinant hormones like insulin, polyclonal antibodies, and antibody fragments. Various excipients, such as buffers, salts, polymers, and preservatives, are crucial for stabilizing cells and modifying their permeability. Excipients play an essential role in formulating therapeutic proteins, such as recombinant human growth hormone (rhGH), ensuring stability from production through to patient administration. These additives are vital for maintaining the integrity of proteins during storage and transport, controlling pH, ensuring stability against environmental stress during lyophilization, adjusting tonicity, and preventing protein aggregation.
• Insight By Scale Of Operation: The commercial segment commands the largest global excipients market share and has exhibited the highest growth rate during the forecast period. The surge in biologics demand, driven by the need to address infectious diseases and pandemics, has escalated the requirement for rapid production of billions of doses within tight timeframes. This presents notable challenges in biopharmaceutical manufacturing, particularly in scaling operations to meet commercial demands while ensuring product consistency and quality. Biologic drugs, including monoclonal antibodies, consist of large amino acid chains that are much larger than conventional small molecule injectables. As these drugs transition into the commercial phase, the demand for excipients becomes substantial. These agents are crucial in biological formulations, contributing to stability, solubility, and overall product effectiveness.
• Insight By Origin: The global biopharmaceutical excipients market, segmented by origin, is predominantly composed of organic excipients, which hold the largest market share. Advances in extraction and purification technologies have simplified the production of high-quality organic excipients, leading to increased adoption. The biopharmaceutical excipient market is shifting toward organic options due to several factors, including safety, biocompatibility, and consumer preferences. Organic excipients, made from natural substances such as polysaccharides, proteins, lipids, and organic acids, are gaining popularity in biopharmaceutical formulations. They offer numerous advantages over synthetic alternatives, including lower toxicity, improved patient compliance, and enhanced compatibility with active pharmaceutical ingredients (APIs) used in biologics and other complex medications.
• Insight By End-User: The segment of Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) is experiencing significant growth and is projected to have the highest CAGR during the forecast period. Biopharmaceuticals differ notably from traditional small molecule drugs in their large molecular size and complex production processes, influencing their behavior and therapeutic effects within the body. Due to the challenges involved in biopharma manufacturing, a growing number of companies are turning to CMOs and CDMOs for their specialized expertise and resources. This outsourcing strategy allows biopharma developers to focus on product commercialization and clinical development while leveraging the capabilities of these organizations. As a result, CMO sales have seen steady growth, fueled by both increased outsourcing and the expansion of new and existing product lines, including services for clinical trial supplies.

GEOGRAPHICAL ANALYSIS

APAC is witnessing substantial growth and stands out as the fastest-growing area in the global biopharmaceutical excipients market. This expansion is driven by several crucial factors, including the growing pharmaceutical industry, advancements in functional excipients, and heightened use of orphan drugs. The rise of multifunctional excipients and the transition of pharmaceutical manufacturing to emerging markets further bolster these growth prospects. Additionally, the burgeoning biosimilar industry in APAC offers new opportunities for the development of excipients used in biopharmaceutical formulations. The region is also experiencing a growing patient population, particularly those suffering from cancer, which is recognized as the second leading cause of death worldwide.

COMPETITIVE LANDSCAPE

The global biopharmaceutical excipients market report highlights exclusive insights into 36 vendors. This market is notable for its diversity, featuring a mix of emerging mid-sized firms and established industry leaders that contribute to overall revenue. Key players are adopting various strategies to enhance their market presence and share, including new product launches, securing regulatory approvals, undertaking marketing initiatives, investing significantly in research and development, and bolstering distribution networks. Major participants like Merck KGaA, BASF SE, Avantor, Evonik Industries, and Roquette Freres are also focusing on strategic licensing agreements, acquisitions, and collaborations with emerging firms to swiftly enter the biopharmaceutical excipients market and access commercially available products. Expanding into both existing and new markets to satisfy a growing customer base, broadening product portfolios, and improving production capabilities are vital strategies for attracting end-users.